Actively Recruiting
Comparisons Of Biochemical And Clinical Outcomes Of Hemodialysis Patients Treated With Middle Cut-Off Dialyzers Versus High-Flux Hemodialysis Or Hemodiafiltration
Led by Arbor Research Collaborative for Health · Updated on 2026-05-01
1000
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating clinical and biochemical outcomes in patients with end-stage kidney disease (ESKD) undergoing maintenance hemodialysis. This observational study compares the use of medium cut-off (MCO) dialyzers (Theranova) with high-flux hemodialysis (HF-HD) and hemodiafiltration (HDF). The goal is to determine whether MCO dialyzers are linked to better survival and health outcomes compared to HF-HD, and whether they perform at least as well as HDF. The study is motivated by high mortality rates among dialysis patients and variations in treatment outcomes across regions. The study uses real-world data from non-DOPPS centers using Theranova dialyzers and compares this to external control data from the DOPPS cohort, which includes patients treated with HF-HD and HDF. This retrospective design involves collecting data on patients' demographics, comorbidities, dialysis prescriptions, and laboratory results. Participants are adults receiving in-center maintenance hemodialysis. Data collection spans from March to June 2026 and includes approximately 500 to 1000 Theranova patients alongside control groups. During the study, researchers will review all-cause mortality over three years as the primary outcome. Secondary outcomes include cardiovascular events, infections, hospitalizations, and biochemical measures related to anemia, mineral balance, and inflammation. Patient data privacy is ensured through pseudonymization techniques. Statistical methods will adjust for differences in patient characteristics to fairly compare outcomes across groups. This study aims to provide meaningful real-world evidence about the effectiveness of MCO dialyzers to inform clinical practice and future research.
CONDITIONS
Brief Title
Comparisons Of Biochemical And Clinical Outcomes Of Hemodialysis Patients Treated With Middle Cut-Off Dialyzers Versus High-Flux Hemodialysis Or Hemodiafiltration
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Treated at an in-centre dialysis clinic
- Receiving chronic, maintenance hemodialysis
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants who undergo routine hemodialysis are observed to collect data on clinical outcomes, biochemical parameters, and treatment characteristics.
Data collected during routine dialysis visits
Trial Site Locations
Total: 1 location
1
AURA
Paris, France
Actively Recruiting
Research Team
R
Roberto Pecoits-filho, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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